Patient Safety Act Calls for Voluntary Error Reporting

For more than two years, the Department of Health and Human Services (HHS) has talked about adopting standards for health-IT. Now that idea is written into law. Included in a new federal statute calling for the voluntary reporting of medical errors and other incidents of compromised patient safety is a stipulation that HHS develop or adopt national standards for integration of health-IT systems.

An aide to Sen. James Jeffords (I-Vt.), who sponsored the Patient Safety and Quality Improvement Act of 2005, says that lawmakers intentionally made this provision vague to give HHS as much leeway as possible in identifying standards. President Bush signed the bill into law on Friday.

The new law primarily calls for voluntary reporting of medical errors to "promote the development of interventions and solutions to ensure that such errors will not be repeated," according to the text of the legislation.

Healthcare providers are asked to report medical errors, "near misses," and "enhanced" quality practices to HHS-designated organizations that will analyze reported information and develop guidance for providers on how to improve the quality of care in America.

These organizations, public or private entities called patient safety organizations (PSOs), will have the authority to publicize their findings on recommended interventions and other best practices. HHS will develop guidelines for PSOs, including the process to apply to be one of the organizations.

The Jeffords aide says that a voluntary system creates an "environment of trust" and allows for better accuracy. Reports to PSOs will be considered confidential and legally privileged, unless a court determines that the information contains evidence of criminal activity. This protection does not extend to medical records and other information not directly related to the "patient safety process," however.

Patient safety advocate Donald Berwick, M.D., president and chief executive of the Institute for Healthcare Improvement (Cambridge, Mass.), says that voluntary reporting likely is the best way to go, though he reserves his judgment.

"One can have an illusion of requiring it, but, in the arena of safety, usually there is a tremendous proportion of judgment involved. Therefore, for the most part, good reporting is a matter of culture," Berwick says in an e-mailed response to written questions. "Therefore, for the most part, good reporting is a matter of culture." Berwick adds, "We will know more about the effectiveness of this legislation when we can see the volume of reports that begins to emerge."

According to Berwick, reporting is just the first step in a long process. "Improvement requires sophisticated analyses, case studies, and remedial actions over time, learning as we go," he says.

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